Devices for Handling Catheter Assembly

ABSTRACT

A gripping device for a catheter assembly is disclosed providing enhanced gripping power for the operator of the catheter assembly. The gripping device is situated at the proximal portion of the catheter assembly and the proximal terminus of an external catheter sheath is attached near or to the body of the gripping device.

This application is a continuation of U.S. patent application Ser. No.13/103,626, filed May 9, 2011, now U.S. Pat. No. 8,771,286; which is acontinuation of U.S. patent application Ser. No. 12/578,092, filed Oct.13, 2009, now U.S. Pat. No. 7,938,838; which is a continuation of U.S.patent application Ser. No. 11/487,487, filed Jul. 17, 2006, now U.S.Pat. No. 7,601,158; the contents of which are hereby incorporated byreference herein in their entirety into this disclosure.

BACKGROUND OF THE INVENTION

1. Field of the Invention

The present invention relates generally to catheter assemblies. Moreparticularly, the present invention relates to a grip for a proximalportion of a catheter assembly.

2. Background of the Invention

In hospital settings today, nurses often perform urinary catheterizationprocedures using convenience packs, or pre-assembled kits, whichtypically contain a vinyl or red latex rubber catheter, a waterproofabsorbent underpad, a fenestrated drape, disposable gloves, a sealedpacket containing about 22.5 mL of Povidone-Iodine solution, fiveprepping cotton balls in a disposable tray compartment, a sealed packetcontaining sterile lubricating jelly, a plastic forceps, a sterilespecimen bottle, and a 1000 mL graduated basin. All of these items arepackaged together and sterilized.

To perform the catheterization procedure, a nurse opens the tray, donssterile gloves and places the drape around the patient's genitalia. ThePovidone-Iodine packet is opened and poured over the five cotton balls.The packet of lubricating jelly is then opened and squeezed onto asterile field. The patient's urethral opening is cleansed with the fivesaturated cotton balls, holding each cotton ball with the forceps. Then,the nurse runs the tip end of the catheter, comprising the first inch ortwo (about 2.5 cm to about 5 cm) of the insertable portion, through thelubricating jelly. The catheter is then inserted into the patient'surethra and advanced until urine begins to flow through the catheter.The urine is drained into the receptacle and a urine specimen is caughtin the specimen bottle if needed. The catheter is then removed and allthe aforementioned items are discarded. Care must be taken during thesesteps to maintain sterile technique in order to reduce the risk ofurinary tract infection. Because multiple steps are involved in thecatheterization procedure and meticulous attention to maintain steriletechnique is required, a nurse typically spends a significant amount oftime (e.g., 10-15 minutes) carrying out each catheterization. This basicprocedure is used in virtually every inpatient hospital around theworld, and has remained essentially the same for 50 years.

Thus, there is a need in the healthcare industry for a simplified andstreamlined inpatient catheterization procedure to eliminate the stepsthat compromise sterile technique and reduce the amount of time spentper patient on the catheterization process.

SUMMARY OF THE INVENTION

The current techniques for inpatient catheterization are inefficient. Inconventional catheterization techniques, a small portion (about 1″-2″)of a catheter tip is manually lubricated before insertion into apatient's urethra. While holding the patient's genitalia with one hand,the nurse grasps the catheter body with the other hand and guides thelubricated catheter tip into the patient's urethra. Such contact withthe catheter may result in contamination if proper sterile technique isnot used. Additionally, the nurse has only a limited ability to guidethe catheter into the patient's urethra and insert the catheter fartherinto the patient's urethra since only one hand is free to perform theseoperations. Thus, the inefficiency in conventional urinarycatheterization results from the many meticulous steps required tomaintain sterile technique along with the operator's inability toeffectively guide and insert the catheter. In order to address thishealthcare problem, the present invention provides techniques for moreeasily gripping and manipulating a catheter assembly while maintaining asterile procedure even though sterile technique is not employed. Morespecifically, the present invention proposes a gripping device on aproximal portion of a catheter assembly to increase dexterity of thecatheter assembly with an introducer tip being inserted into thepatient's urethra prior to catheter insertion thereby freeing theoperator's other hand to guide and insert the catheter into thepatient's urethra.

In one exemplary embodiment, the present invention is a gripping devicefor a catheter assembly. The device includes a gripping body situated ata proximal portion of a catheter assembly; the gripping body includingan adhesive portion for sheath attachment, and an apertured centerportion for catheter guidance.

In another exemplary embodiment, the present invention is a grippingdevice for a catheter assembly. The device includes a cylindricallyshaped gripping body with concave lateral portions with a distal half ofthe gripping body located within a sheath and a proximal half of thegripping body situated external to the sheath; a collar located on amiddle portion of the gripping body, the collar receiving a proximalterminus of the sheath; a throughbore positioned in a middle portion ofthe gripping body so as to allow guidance of a catheter therethrough;and an apertured center portion of the gripping body comprising aslitted penetrable barrier including multiple flaps, the barrierpiercable by the catheter upon insertion.

In yet another exemplary embodiment, the present invention is a catheterassembly. The assembly includes a gripping body grippable by anoperator's hand; a connected introducer body proximal to the grippingbody; and a catheter situated within a surrounding sheath which isgrippable by the operator's other hand.

In one of the exemplary embodiments of the present invention, a proximalend of the catheter assembly is equipped with an introducer, and aguiding portion composed of a cylindrical gripping device attached to anexternal protective sheath. With this exemplary embodiment, the operatoris provided with a gripping surface which may be textured (e.g,corrugated in a particular pattern) which can be used to stabilize thecatheter assembly during insertion of the catheter through theintroducer into the patient's urethra.

In another exemplary embodiment, the gripping device is conical in shapewith a textured or corrugated surface in order to provide an alternativedesign to enhance the operator's dexterity.

In yet another exemplary embodiment, the gripping device is a part of anexternal textured collar where the sheath is attached. This exemplaryembodiment may include an internal collar as well.

In yet another embodiment of the present invention, the gripping deviceis cylindrically shaped with concave lateral portions so as to increaseoperator dexterity. This exemplary embodiment may be composed of twointroducer portions as well for optimal catheter guidance.

As used herein and throughout this disclosure, and in order tounderstand the directional aspects of this invention, “proximal” refersto the section of the device that is closer to the patient's body (e.g.,urethra) while “distal” refers to the section of the device that isfarther away from the body, or closer to the back-end of the catheterassembly used to connect to a collection receptacle.

BRIEF DESCRIPTION OF THE DRAWINGS

FIG. 1 shows a side view of a cylindrically shaped gripping deviceaccording to an exemplary embodiment of the present invention.

FIG. 2 shows a side view of a conically shaped gripping device accordingto an exemplary embodiment of the present invention.

FIG. 3 shows a side view of a textured collar proximal gripping deviceaccording to an exemplary embodiment of the present invention.

FIG. 4 shows a side view of a cylindrically shaped gripping device withlateral concave portions according to an exemplary embodiment of thepresent invention.

FIG. 5 shows a side view of a smooth transition bipyramidal shapedgripping device according to an exemplary embodiment of the presentinvention.

FIG. 6 shows a side view of a sharp transition bipyramidal shapedgripping device according to an exemplary embodiment of the presentinvention.

DETAILED DESCRIPTION OF THE INVENTION

The present invention provides for catheter and catheter assemblies witheasy-gripping handle portions such that such catheter and catheterassemblies are more readily manipulated in and around the body. Inparticular embodiments and examples presented herein, such catheters aredescribed with respect to urinary catheterization but it must be notedthat such handles and grips according to the present invention are notlimited to urinary catheters alone but may be applicable to any catheterand catheter assembly that could benefit from the use of such handles orgrips. Furthermore, the present invention allows for more efficient andsecure handling of catheter and catheter assemblies to decrease the timerequired for and increase the safety and reliability of catheterizationand associated procedures.

An exemplary embodiment of the present invention as used in catheterassembly 100 is shown in FIG. 1. Assembly 100 includes a cylindricallyshaped gripping body 110, a protective sheath 120, a catheter 130, anoptional first collar 117, a second collar 113, and an introducer 115.The gripping body 100 may also contain one or more venting channels 119to assist in the movement of the sheath. The venting channels 119 canfurther enclose optional filters or membranes 118. The catheter 130 maybe composed of a conventional material commonly used in the catheterarts or it may be composed of a hydrophilic material in order to furtherlubricate the catheter 130.

The protective sheath 120 may be attached to the gripping body 110 atattachment site 111 at a proximal terminus 121 of the protective sheath120 as depicted in FIG. 1. In this exemplary embodiment, about half ofthe gripping body 110 is situated inside the protective sheath 120 whilethe other half of the gripping body 110 is situated outside theprotective sheath 120. The optional venting channels 119 may belongitudinal cut-outs running the length of the gripping body 110 suchthat the protective sheath 120 makes contact with the surface of thecut-outs thereby forming a space between the attachment site 111 and thebottom of the longitudinal cut-outs such that gas (e.g., built-up air)is able to escape from inside the protective sheath 120 to the externalenvironment during manipulation of catheter assembly 100. The optionalventing channels 119 may be covered by optional filters or membranes 118so that care is taken to maintain a contamination free environment. Theoptional filters or membranes 118 may be composed of a standard materialcommonly used in the catheter arts such that they are permeable to gases(e.g., N₂ and O₂) thereby allowing air to escape through the optionalfilters or membranes 118 from the inside of the protective sheath 120 tothe external environment. Such a permeable material may include, but isnot limited to, polyimide copolymers and may effectively keep outbacterial or viral contaminants from inside the catheter assembly 100.

The protective sheath 120 may also be attached via attachment site 111on any other portion of the gripping body 110 including the regionspanning from and including the distal, backside of optional firstcollar 117 to the proximal, front side of the second collar 113. Thus,the gripping body 110 may be entirely situated external or internal tothe protective sheath 120. These variations would not utilize theoptional venting channels 119. The protective sheath 120 can be attachedat attachment site 111 to the gripping body 110 by various attachmentmethods known to one having ordinary skill in the art as long as care istaken to maintain a contamination free environment (e.g., adhesion, heatsealing, snap collaring). The protective sheath 120 may serve tomaintain catheter sterility and provide a chamber for additionallubricant or aqueous solution for the catheter 130.

In the assembled, unused or pre-used form of catheter assembly 100, thecatheter tip 112 may be retained proximal to a distal end of thegripping body 110 (which could be at optional first collar 117), anddistal to the proximal tip 116 of the introducer 115. Thus, the cathetertip 112 may be situated anywhere inside the gripping body 110 distal toaperture 114 or anywhere inside the introducer 115 proximal to aperture114. Such a position for the catheter tip 112 allows for the catheter130 from falling back out of the body 110 and into the sheath 120. Also,there could be slits or a membrane at the far distal end of the body 110or at any location along the body including the aperture at 112. Thisagain would further act to keep the catheter 130 from falling backwardsinto the sheath 120.

In order to guide the catheter 130, the optional first collar 117 maycontain a throughbore of a slightly larger diameter than catheter 130,and it may also contain a slitted diaphragm or membrane (not shown)apertured in such a way so as to provide the catheter 130 a stable andcontrolled passageway (e.g., a slitted design with 4 flaps). Thisslitted diaphragm or membrane (not shown) at the distal, backside ofoptional first collar 117 may be pierced by the catheter tip 112 in theunused form and may function to prevent the catheter 130 from fallingback into the protective sheath 120. Also, the catheter assembly 100 mayhave other slitted diaphragms or membranes (not shown) along the insideof the gripping body 110, at the aperture 114, and along inside theinside of introducer 115. These slitted diaphragms or membranes (notshown) may further act to prevent the catheter 130 from falling backinto the protective sheath 120 and out of the gripping body 110, and mayalso help stabilize and secure the passage of catheter 130 throughcatheter assembly 100. The optional first collar 117 may provideenhanced operator dexterity of the catheter assembly 100 and can be usedto support the bottom of the operator's hand during catheter insertion.The gripping body 110 may be of a length such that the operator is ableto grasp the gripping body 110 with at least the index finger and thumb.The gripping body 110 may also be textured or corrugated to provideincreased operator dexterity as well.

During a routine catheterization process, the gripping body 110 may begrasped such that the operator's hand and fingers are distal to andunderneath the second collar 113 or such that the operator's indexfinger and thumb are on the surface of second collar 113 or on thepatient's penis while taking care to minimize contamination of thecatheter 130. The operator's other hand may be used to grasp thepatient's genitalia as well. The introducer 115 may be introduced intothe patient's urethra to stabilize the catheter assembly 100 such thatthe operator is able to release the patient's genitalia and use thenewly freed hand to guide and insert the catheter 130 through thegripping body 110, into the introducer 115, and then into the patient'surethra. The inside of the gripping body 110 may have a slightly largerdiameter than the diameter of the catheter 130 to allow for catheter 130to pass through smoothly and unimpeded. Additionally, the inside of thegripping body 110 may contain a lubricant chamber to keep lubricated theportion of catheter 130 just distal to the catheter tip 112. Thischamber can be formed by a variety of ways, including, for example, thatshown by U.S. Pat. No. 6,090,075, entitled “Disposable UrinaryCatheterization Assembly,” issued on Jul. 18, 2000, and herebyincorporated by reference herein in its entirety. Such chamber mayinclude a compartmentalized portion housing the lubricant or aqueoussolution with a penetrable distal diaphragm or membrane for the cathetertip 112 to pierce and thereby be exposed to the lubricant or aqueoussolution.

The catheter 130 is then guided through an aperture 114 of the secondcollar 113, which may be textured or corrugated to provide increasedoperator dexterity. The gripping body 110 may either be connected to thesecond collar 113 and introducer 115 (e.g, forming a single proximalpiece) or the gripping body 110 may be separate from the second collar113 and the introducer 115 with the second collar 113 and the introducer115 being attachable to the gripping body 110 (e.g., forming two or moredistinct proximal pieces). The aperture 114 of second collar 113 may beslitted (e.g., forming four flaps) or contain a slitted diaphragm ormembrane (not shown) to allow a more stable and controlled passage forthe proximal tip 112 and the rest of the body of the catheter 130. Theslitted diaphragm or membrane (not shown) would prevent lubricant oraqueous solution from prematurely entering into the introducer 115thereby providing a lubricant chamber inside gripping body 110.

Next, the catheter tip 112 may be guided through the introducer 115,which has a slightly larger diameter than the catheter 130 and maycontain lubricant or aqueous solution as well to allow the catheter 130to pass smoothly therethrough. The introducer 115 may also contain asingle or multiple slitted diaphragms or membranes (not shown) which canenhance dexterity and catheter guidance. The proximal tip 116 ofintroducer 115 may have a slitted tip portion 141 (e.g., forming four ormore flaps) to provide a controlled passageway for the catheter tip 112and catheter 130. If lubricant or aqueous solution is stored in theintroducer 115, then a removable seal at the slitted tip portion 141would contain the lubricant or aqueous solution inside the introducer115 providing a contamination-free housing portion.

Use and introduction of the catheter 130 of catheter assembly 100 into apatient, for example, within the urethral opening, is facilitated by theinclusion of the gripping body 110 located substantially between, or“book-ended” by, the optional first collar 117 and the second collar113. Such gripping body 110 being securely fastened to the catheterassembly 100 allows the user, be it caretaker or patient, to moresecurely hold the assembly in proper place and more accurately directthe catheter tip 112 into the patient's urethra.

Another exemplary embodiment of the present invention incorporated intoa catheter assembly 200 is shown in FIG. 2, and includes a conicallyshaped gripping body 210 with optional projections 218, a catheter 230,a collar 213, an introducer 215, and a protective sheath 220. Thecatheter 230 may be composed of a conventional material regularly usedin the art or it may be composed of a hydrophilic material in order tofurther lubricate the catheter 230. Also, the gripping body 210 may betextured or corrugated to enhance operator dexterity. The protectivesheath 220 functions to maintain catheter sterility and provide a volumefor additional catheter lubricant or aqueous solution.

The protective sheath 220 may be attached to the gripping body 210 atattachment site 211 at the proximal terminus 221 of the protectivesheath as depicted in FIG. 2. The protective sheath 220 may also beattached via attachment site 211 to any other portion of the grippingbody 210 ranging from and including the distal surface 217 to theproximal, front side of collar 213. Thus, the gripping body 210 may beentirely situated external or internal to the protective sheath 220 aswell. The connection at attachment site 211 may be made possible byvarious attachment methods known to one having ordinary skill in the artas long as care is taken to maintain a contamination free environment.

The gripping body 210 may also possess optional projections 218 toprovide a better surface for attachment site 211 or to provide increasedoperator dexterity of the gripping body 210. These optional projections218 may be individual and independent tabs located at numerous positionsalong the circular distal end of the gripping body 210. Alternatively,the optional projections 218 may be a single ring spanning and coveringthe entire distal end of gripping body 210 and acting as a small collarpositioned substantially perpendicularly to the axis of the catheter230. In either way described or other ways possible, the optionalprojections 218 could improve dexterity of the operator's hand andadditionally provide a better seal between the proximal terminus 221 ofthe protective sheath 220 and the gripping body 210. The distal surface217 of the gripping body 210 may contain a throughbore with a slightlylarger diameter than catheter 230. The distal surface 217 may alsocontain a slitted diaphragm or membrane (not shown) which may act toprevent the catheter 230 from falling back into the protective sheath220, and also act to provide the catheter 230 with a stable and securepassageway through the gripping body 210. The gripping body 210 may beof a length such that the operator is able to grasp the gripping body210 with at least the index finger and thumb. The gripping body 210 mayalso be textured or corrugated to provide increased operator dexterityas well.

During catheter insertion, the catheter 230 is introduced through thedistal surface 217 of the gripping body 210. The gripping body 210 maybe grasped such that the operator's hand and fingers are distal to andunderneath the collar 213 or such that the operator's index finger andthumb are on the surface of collar 213 or on the patient's penis whiletaking care to minimize contamination of the catheter 230. Theoperator's other hand may be used to grasp the patient's genitalia aswell. The introducer 215 may be introduced into the patient's urethra tostabilize the catheter assembly 200 such that the operator is able torelease the patient's genitalia and use the newly freed hand to guideand insert the catheter 230 through the gripping body 210, into theintroducer 215, and then into the patient's urethra. In order tofacilitate the passage of catheter 230 through the gripping body 210,the gripping body 210 may contain a lubricant or aqueous solution, or itmay house a lubricant chamber. Such chamber may include acompartmentalized portion housing the lubricant or aqueous solution witha penetrable distal diaphragm or membrane for the catheter tip 212 topierce and thereby be exposed to the lubricant or aqueous solution. Thepatent cited above, and incorporated by reference herein, may beconsulted to consider types of lubricant chambers that may be used.

The gripping body 210 may be connected to the collar 213 and theintroducer 215 (e.g., forming a single proximal piece) or the grippingbody 210 may be separate from the collar 213 and introducer 215 with thecollar 213 and the introducer 215 being attachable to the gripping body210 (e.g., forming two or more separate proximal pieces). The cathetertip 212 is then manipulated through the aperture 214 of collar 213during catheter insertion. The collar 213 may be textured or corrugatedso as to provide additional operator dexterity for the operator's indexfinger and thumb. The aperture 214 may be a throughbore of a slightlylarger diameter than the catheter 230. The aperture 214 may also containa slitted diaphragm or membrane (not shown) to provide a more stable andcontrolled passageway for the catheter 230. The catheter 230 is thenguided through the introducer 215, which has a slightly larger diameterthan catheter 230 and may contain lubricant or aqueous solution as well.The introducer may also contain a single or multiple slitted diaphragmsor membranes (not shown) to enhance dexterity and catheter guidance.

The proximal tip 216 of introducer 215 may have a slitted tip portion241 (e.g., forming four or more flaps) to provide a controlledpassageway for the catheter tip 212 and catheter 230. If lubricant oraqueous solution is stored in the introducer 215, then a removable sealat the slitted tip portion 241 would contain the lubricant or aqueoussolution inside the introducer 215 providing a contamination-freehousing portion.

In the pre-used form of catheter assembly 200, the catheter tip 212 maybe retained proximal to distal surface 217 and distal to the proximaltip 216 of the introducer 215 similar to as described above.

The particular conical gripping body 210 presented in the assembly 200shown in FIG. 2 has many advantages. For example, the conical shapeallows a better grip of the assembly 200 by taking into account thetapered design of the conical shape and its accommodation of the hand.The conical shape of the grip 210 allows the user's hand to leanproximally or exert additional pressure or gripping power to theproximal end of the grip 210 because the hand and fingers naturallyslide from a wider cross section of the grip 210 to a narrower crosssection. Thus, the user's hand is naturally forced to exert bettergripping power at the narrower, and more proximal end, of the grip 210,thereby allowing additional accuracy during the insertion process of thecatheter tip 212 into the urethra. However, the present invention is notlimited to a conical shape that is presented in FIG. 2, and may alsoinclude a conically shaped gripping body 210 with its tapered end beingreversed with a larger diameter end positioned more proximal and anarrower diameter end positioned more distal.

Another exemplary embodiment of the present invention incorporated intoa catheter assembly 300 is shown in FIG. 3. The assembly 300 includes acatheter 330, an optional first collar 333, a guide portion 332, asecond collar 313 with a textured surface 334 for enhancing grippingpower, proximal projections 317, distal projections 318, a sheath 320,and an introducer 315. The distal projections 318 and proximalprojections 317 may be depicted as shown in FIG. 3 as isolated, axialprojections or they may be circumferential such that they form singlerings spanning and covering either surface of the second collar 313 andacting as small collars positioned substantially perpendicularly to theaxis of the catheter 330.

The catheter 330 may be constructed of a conventional material used inthe art or it may be composed of a hydrophilic material in order tofurther lubricate the catheter 330. The protective sheath 320 may beattached to the second collar 313 at attachment site 311 at the proximalterminus 321 of the protective sheath 320 as depicted in FIG. 3. Theprotective sheath 320 functions to maintain a sterile environment forthe catheter 330 and also to house a volume of lubricant or aqueoussolution for the catheter 330. The attachment site 311 may be sealed tothe second collar 313 by various adhesive methods known to one havingordinary skill in the art as described above as long as care is taken tomaintain a contamination free environment. Alternatively, the protectivesheath 320 may be attached via attachment site 311 anywhere between andincluding the distal side of optional first collar 333 to the proximalside of second collar 313. In this way, the optional first collar 333along with the guide portion 332 and second collar 313 can be situatedoutside of the protective sheath 320, or the optional first collar 333along with a segment of the guide portion 332 can be situated inside theprotective sheath 320 as well.

The catheter assembly 300 may include a guide portion 332 attached to adistal side of the second collar 313. The guide portion 332 may be of aslightly larger diameter than the catheter 330. An optional first collar333 may be attached to the guide portion 332 to provide increasedoperator dexterity of the catheter 330 and catheter assembly 300. Theoptional first collar 333 may contain a throughbore of a slightly largerdiameter than catheter 330 and it may contain a diaphragm or membranewith a slitted portion 334 forming multiple flaps to enhance cathetermanipulation during insertion and also to prevent the catheter fromfalling back into the protective sheath 320. The guide portion 332 mayalso contain a single or multiple slitted diaphragms or membranes (notshown) inside of its length which serve to enhance catheterstabilization and guidance. There may be stored lubricant 331 or aqueoussolution, or a lubricant chamber within the guide portion 332 as well.The lubricant 331 is depicted in FIG. 3 as morphous gel-like particlesfor the sake of simplicity. The lubricant 331 can be in thiswell-defined form as depicted or it can be more aqueously defined. Thelubricant chamber can vary in design but may include a compartmentalizedportion housing the lubricant or aqueous solution with a penetrabledistal diaphragm or membrane for the catheter tip 312 to pierce andthereby be exposed to the lubricant or aqueous solution.

During catheterization, the optional first collar 333 and the guideportion 332 may be grasped such that the operator's hand and fingers aredistal to and underneath the second collar 313 or such that theoperator's index finger and thumb are on the surface of second collar313 or on the patient's penis while taking care to minimizecontamination of the catheter 330. The operator's other hand may be usedto grasp the patient's genitalia as well. The optional first collar 333may serve as a backstop to the operator's hand or it may simply increasethe operator's dexterity and handling of the catheter assembly 300. Theintroducer 315 may be introduced into the patient's urethra to stabilizethe catheter assembly 300 such that the operator is able to release thepatient's genitalia and use the newly freed hand to guide and insert thecatheter 330 through the guide portion 332 into the introducer 315, andthen into the patient's urethra. The aperture 314 may be of a slightlylarger diameter than catheter 330 and it may contain a slitted diaphragmor membrane (not shown) forming multiple flaps for the catheter to passsmoothly therethrough. The second collar 313 may possess proximalprojections 317 to prevent the operator's index finger and thumb fromslipping off. The second collar 313 may also possess distal projections318 to provide a better surface for attachment site 311 or to provideincreased operator dexterity.

The catheter tip 312 is then manipulated through aperture 314 into theintroducer 315. The introducer 315 may contain a single or multipleslitted diaphragms or membranes (not shown) which serve to enhancecatheter stabilization and guidance. The introducer 315 may also containlubricant 331 or aqueous solution. The introducer 315 may be of aslightly larger diameter than catheter 330 and may possess a slitted tipportion 341 forming multiple flaps. If lubricant or aqueous solution isstored within the introducer 315, then a seal may placed on the proximaltip 316 to keep the catheter 330 sterile and provide a barrierpreventing contamination.

In the pre-used form of catheter assembly 300, the catheter tip 312 maybe retained proximal to the optional first collar 333 and distal to theproximal tip 316 of the introducer 315 similar to as described above.

Use and introduction of the catheter 330 of catheter assembly 300 into apatient, for example, within the urethral opening, is facilitated by theinclusion of the second collar 313 located substantially outside of theprotective sheath 320.

The user may also hold the guide portion 332 or optional first collar333 through force exerted on the surface of the protective sheath 320.Because the guide portion 332 may securely fasten the optional firstcollar 333 to the second collar 313, a “dumbbell” shape is created toserve as a substantially rigid holding point for a user to hold ontowhile directing the catheter 330 into a body cavity, such as theurethral opening. The guide portion 332 may be of a length such that theoperators can grasp it using the thumb and index finger.

Another exemplary embodiment of the present invention incorporated intoa catheter assembly 400 is shown in FIG. 4. The assembly 400 includes acylindrically shaped gripping body 410 with concave lateral portions, aseal 411, a catheter 430, a first introducer 418, a second introducer415, and a protective sheath 420. The catheter 430 may be constructedfrom a conventional material regularly used in the art or it may becomposed of a hydrophilic material in order to further lubricate thecatheter 430.

The seal 411 divides the gripping body 410 into a first gripping portion410 a and a second gripping portion 410 b as depicted in FIG. 4.However, the seal may be positioned anywhere along the gripping body 410from and including the distal side of the first gripping portion 410 ato the surface of collar 413. The seal 411 may be accomplished byvarious attachment methods as described above while taking care tomaintain a contamination free environment. The seal 411 may adhere theproximal terminus 421 of the protective sheath 420 to the gripping body410, thus preserving a sterile internal environment within theprotective sheath 420. The protective sheath 420 also functions to holda volume of lubricant or aqueous solution for catheter 430. The firstgripping portion 410 a may be located within the protective sheath 420while the second gripping portion 410 b may located outside of theprotective sheath 420 as depicted in FIG. 4. Alternatively, the firstgripping portion 410 a and the second gripping portion 410 b may belocated entirely inside of or outside of the protective sheath 420depending on the location of seal 411.

In the pre-used form of catheter assembly 400, the catheter tip may beretained proximal to the first aperture 417 and distal to the proximaltip 416. The first aperture 417 may be of a slightly larger diameterthan the catheter 430 and it may contain a slitted diaphragm or membrane(not shown) forming multiple flaps thereby preventing the catheter 430from falling back into the protective sheath 420 and also enhancingcatheter stability. The first introducer 418 may have a throughbore of aslightly larger diameter than the catheter 430 to provide a smoothpassageway for catheter 430. The first introducer 418 could be eitherconnected to the collar 413 and gripping body 410, or the firstintroducer 418 could be a separate piece distinct from the gripping body410 with its own attachment site to the first gripping portion 410 a.The gripping body 410 could also be a detachable piece with the secondgripping portion 410 b being attached just proximal to the seal 411. Inthis way, the second gripping portion 410 b could be detached from thegripping body 410 so that additional lubricant or aqueous solution couldbe added to the catheter 430 or inside the second introducer 415 ifnecessary while maintaining a sterile internal environment.

During use, the operator guides the catheter 430 through the firstintroducer 418 from just proximal to the first aperture 417 to thesecond aperture 414 of the collar 413. The first introducer 418 may alsocontain inside its length a single or multiple slitted diaphragms ormembranes (not shown) to enhance catheter stability. The first grippingportion 410 a and the second gripping portion 410 b may be of a lengthsuch that the operator's hand and fingers may grasp distal to andunderneath the collar 413. The operator may also grasp the surface ofcollar 413 with the index finger and thumb or the operator may grasp thepatient's penis with the index finger and thumb while taking care tominimize contamination of the catheter 430. The operator's other handmay be used to grasp the patient's genitalia as well. The first grippingportion 410 a and the second gripping portion 410 b may both serve asbackstops to the operator's hand or they may simply increase theoperator's dexterity and handling of the catheter assembly 400. Thesecond introducer 415 may be introduced into the patient's urethra tostabilize the catheter assembly 400 such that the operator is able torelease the patient's genitalia and use the newly freed hand to guideand insert the catheter 430 through the first introducer 418 into thesecond introducer 415, and then into the patient's urethra. The secondaperture 414 may be of a slightly larger diameter than the catheter 430and it may contain a slitted diaphragm or membrane 442 forming multipleflaps on the center portion 419 of the collar 413. The first introducer418 may contain lubricant or aqueous solution, or a lubricant chamberwith the slitted diaphragm or membrane 442 in the second aperture 414 oncollar 413 acting to prevent lubricant leakage. Such chamber may includea compartmentalized portion housing the lubricant or aqueous solutionwith a penetrable distal diaphragm or membrane for the catheter tip 412to pierce and thereby be exposed to the lubricant or aqueous solution.

The catheter 430 is then guided through the second aperture 414 and intothe second introducer 415. The second introducer 415 may be situated ontop of collar 413 which may also be textured or corrugated to enhancegripping power. The second introducer 415 may also contain lubricant oraqueous solution or a lubricant chamber. The second introducer 415 mayalso contain a single or multiple slitted diaphragms or membranes (notshown) along the inside of its length to enhance catheter stability andguidance. The proximal tip 416 of the second introducer 415 may containa slitted tip portion 441 forming multiple flaps for catheter guidance.To keep the lubricant and catheter 430 sterile, a removable seal couldbe placed on the proximal tip 416. A variation of the exemplaryembodiment of catheter assembly 400 shown in FIG. 4 would lack the firstintroducer 418.

Another exemplary embodiment of the present invention incorporated intoa catheter assembly 500 is shown in FIG. 5. For the sake of simplicity,only the gripping body 510 along with the components particularlyrelevant to this embodiment are labeled. The corresponding componentsfrom FIGS. 1-4 not labeled in FIG. 5 and the parameters associated withsuch components are hereby incorporated into FIG. 5. In this exemplaryembodiment, the gripping body 510 may be bipyramidal in shape with therounded apices 553 of the pyramidal shapes forming convex lateralportions of the gripping body 510. The gripping body 510 may be texturedor corrugated to provide an enhanced gripping surface. The gripping body510 may also contain a throughbore 551 of a diameter slightly largerthan the diameter of catheter 530 such that catheter 530 is able to passthrough the throughbore 551 in a controlled and smooth fashion. Thethroughbore 551 may contain a single or multiple slitted diaphragms ormembranes (not shown) along the inside of its length in order to enhancecatheter guidance. The distal end of the gripping body 510 may alsocontain an aperture 517 which may contain a slitted diaphragm or barrier(not shown) in order to prevent the catheter 530 from falling back intothe protective sheath 520 and in order to enhance catheter guidance. Theattachment site 511 may be located distal to rounded apices 553 asdepicted in FIG. 5 or the attachment site 511 may be located anywherefrom and including the most distal portion of the gripping body 510(e.g. surrounding aperture 517) to the surface of collar 513. Othercombinations, shapes and sizes of the gripping body 510 are alsopossible and within the scope of the present disclosure.

Yet another exemplary embodiment of the present invention incorporatedinto a catheter assembly 600 is shown in FIG. 6. For the sake ofsimplicity, only the gripping body 610 along with the componentsparticularly relevant to this embodiment are labeled. The correspondingcomponents from FIGS. 1-4 not labeled in FIG. 6 and the parametersassociated with such components are hereby incorporated into FIG. 6. Inthis exemplary embodiment, the gripping body 610 may be bipyramidal inshape with the sharp apices 653 of the pyramidal shapes forming convexlateral portions of the gripping body 610. The gripping body 610 may betextured or corrugated to provide an enhanced gripping surface. Thesharp apices 653 may be formed from a 90 degree angle as shown in FIG.6. The gripping body 610 may also contain a throughbore 651 of adiameter slightly larger than the diameter of catheter 630 such thatcatheter 630 is able to pass through the throughbore 651 in a controlledand smooth fashion. The throughbore 651 may contain a single or multipleslitted diaphragms or membranes (not shown) along the inside of itslength in order to enhance catheter guidance. The distal end of thegripping 610 may also contain an aperture 617 which may contain aslitted diaphragm or barrier (not shown) in order to prevent thecatheter 630 from falling back into the protective sheath 620 and inorder to enhance catheter guidance. The attachment site 611 may belocated distal to sharp apices 653 as depicted in FIG. 5 or theattachment site 611 may be located anywhere from and including the mostdistal portion of the gripping body 610 (e.g. surrounding aperture 617)to the surface of collar 613. Other combinations, shapes and sizes ofthe gripping body 610 are also possible and within the scope of thepresent disclosure.

All of the materials used for the present invention may be comprised ofartificial or naturally occurring non-degradable biocompatible polymercompounds such that the materials used for the present invention servethe functions delineated in this application. Such compounds caninclude, but are not limited to, polyester based biocompatible polymers,nylon-based biocompatible polymers, latex based biocompatible polymers,Teflon, polytetrafluoroethylene (PTFE) polymers, polyvinyl chloride(PVC) polymers, silicone polymers, polyurethane polymers, siliconepolyurethane polymers, ethylene-vinyl acetate copolymers, polyethylenepolymers, and thermoplastic polymers. The catheters themselves may alsobe composed of a hydrophilic compound formed from the reaction of anepoxy containing polyvinyl pyrrolidone with a polyamino compound. Thelubricating material includes but is not limited to an aqueous solutionor a hydrogel formed as the reaction product of a siloxane containingmacromer, one hydrophilic polymer, and one compatibilizing component.The lubricating material also may be composed of a biocompatibleantibacterial agent such as a 4-quinolone agent to preventcontamination.

The manufacturing methods that can be employed for the present inventioninclude, but are not limited to, conventional techniques used in theindustry to produce similar function products, as known by a personhaving ordinary skill in the art.

The foregoing disclosure of the exemplary embodiments of the presentinvention has been presented for purposes of illustration anddescription. It is not intended to be exhaustive or to limit theinvention to the precise forms disclosed. Many variations andmodifications of the embodiments described herein will be apparent toone of ordinary skill in the art in light of the above disclosure. Thescope of the invention is to be defined only by the claims appendedhereto, and by their equivalents.

Further, in describing representative embodiments of the presentinvention, the specification may have presented the method and/orprocess of the present invention as a particular sequence of steps.However, to the extent that the method or process does not rely on theparticular order of steps set forth herein, the method or process shouldnot be limited to the particular sequence of steps described. As one ofordinary skill in the art would appreciate, other sequences of steps maybe possible. Therefore, the particular order of the steps set forth inthe specification should not be construed as limitations on the claims.In addition, the claims directed to the method and/or process of thepresent invention should not be limited to the performance of theirsteps in the order written, and one skilled in the art can readilyappreciate that the sequences may be varied and still remain within thespirit and scope of the present invention.

What is claimed is:
 1. A gripping device for a urinary catheter, thedevice comprising: a gripping body located at a proximal portion of theurinary catheter, the gripping body attachable to a sheath; and athroughbore in the gripping body, the throughbore guiding a catheterthrough the gripping body; wherein an operator grasping the grippingbody maintains the grasp without slipping along a longitudinal axis ofthe catheter while moving the catheter through the gripping body.